Efficacy and Safety of LY3298176 - LY3298176 Trial

Oct 09, 2018
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Eli Lilly and Company
Date Published:
10/04/2018
Date Updated:
10/09/2018
Original Posted Date:
10/09/2018
References

Contribution To Literature:

This trial showed that LY3298176 reduced HbA1c in a dose-dependent fashion with an acceptable safety profile. 

Description:

The goal of the trial was to evaluate the novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist LY3298176 compared with placebo or the GLP-1 agonist dulaglutide among patients with type 2 diabetes.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Stratified

Patients with type 2 diabetes were randomized to once-weekly subcutaneous LY3298176 1 mg (n = 53), LY3298176 5 mg (n = 55), LY3298176 10 mg (n = 52), LY3298176 15 mg (n = 53), dulaglutide 1.5 mg (n = 54), or placebo for 26 weeks (n = 51).

  • Total number of enrollees: 318
  • Duration of follow-up: 26 weeks
  • Mean patient age: 57 years
  • Percentage female: 43%
  • Percentage with diabetes: 100%

Inclusion criteria:

  • Patients with type 2 diabetes not well controlled with diet and exercise or with metformin
  • Age 18-75 years
  • Body mass index of 23-50 kg/m²

Principal Findings:

The primary outcome, mean change from baseline in hemoglobin A1c (HbA1c), was -1.06% for LY3298176 1 mg, -1.73% for LY3298176 5 mg, -1.89% for  LY3298176 10 mg, -1.94% for LY3298176 15 mg, and -1.21% for dulaglutide, compared with -0.06% for placebo.

Secondary outcomes:

  • Change in mean bodyweight: -0.9 kg to -11.3 kg for LY3298176 (vs. -0.4 kg for placebo and -2.7 kg for dulaglutide)
  • Any treatment-emergent adverse event: 50% for LY3298176 1 mg, 72.7% for LY3298176 5 mg, 78.4% for LY3298176 10 mg, 84.9% for LY3298176 15 mg, 74.1% for dulaglutide, compared with 52.9% for placebo

Interpretation:

Among patients with type 2 diabetes, GIP and GLP-1 receptor stimulation might offer a new treatment approach. LY3298176 was associated with good treatment efficacy (HbA1c lowering and weight loss) with an acceptable safety profile. 

References:

Frias J, Nauck MA, Van J, et al. Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial. Lancet 2018;Oct 4:[Epub ahead of print].

Clinical Topics: Cardiovascular Care Team, Diabetes and Cardiometabolic Disease, Prevention, Diet

Keywords: Body Weight, Diabetes Mellitus, Type 2, Diet, Glucagon-Like Peptide 1, Glucose, Glycated Hemoglobin A, Metabolic Syndrome, Metformin, Primary Prevention, Treatment Outcome, Weight Loss


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